Temozolomide and Radiation Therapy With or Without Cediranib Maleate in Treating Patients With Newly Diagnosed Glioblastoma

Completed · Phase 2 · Has a placebo group

Conditions studied: Adult Glioblastoma, Adult Gliosarcoma

In brief

This randomized phase II trial studies temozolomide, radiation therapy, and cediranib maleate to see how well they work compared with temozolomide, radiation therapy, and a placebo in treating patients with newly diagnosed glioblastoma (a type of brain tumor). Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether temozolomide and radiation therapy are more effective when given with or without cediranib maleate in treating glioblastoma.

Key facts

Study ID

NCT01062425

Run by

National Cancer Institute (NCI)

People needed

261

Starts

2010-02-26

Expected to finish

2022-05-20

Last updated by the study team

2022-07-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically proven diagnosis of glioblastoma or gliosarcoma (World Health Organization [WHO] grade IV) confirmed by central review prior to step 2 registration
• Tumor tissue that is determined by central pathology review prior to step 2 registration to be of sufficient size for analysis of MGMT status
• Patients must have at least 1 block of tumor tissue; submission of 2 blocks is strongly encouraged
• Cavitron ultrasonic aspirator (CUSA)-derived material is not allowed; fresh frozen tumor tissue acquisition is encouraged
• Diagnosis must be made by surgical excision, either partial or complete; stereotactic biopsy is not allowed because it will not provide sufficient tissue for MGMT analysis
• The tumor tissue must be sent as soon as possible to maximize the likelihood of eligibility; tumor tissue may not be submitted later than 28 days after the surgical procedure, because tissue analysis will not be able to be performed in time for treatment to commence by the mandatory 6-week post-surgery outer limit; submission of tissue earlier than 28 days post-surgery is highly recommended
• The tumor must have a supratentorial component
• History/physical examination, including neurologic examination, within 14 days prior to step 2 registration
• The patient must have recovered from the effects of surgery, post-operative infection, and other complications before step 2 registration
• A diagnostic contrast-enhanced magnetic resonance imaging (MRI) of the brain must be performed preoperatively and postoperatively prior to step 1 registration; the postoperative scan must be performed within 28 days prior to step 1 registration
• Documentation of steroid doses/concurrent medications within 14 days prior to step 2 registration
• Karnofsky performance status >= 70 within 14 days prior to step 2 registration
• Complete blood count (CBC)/differential obtained within 14 days prior to step 2 registration on study, with adequate bone marrow function defined as follows:
• Absolute neutrophil count (ANC) >= 1,800 cells/mm\^3
• Platelets >= 100,000 cells/mm\^3
• Hemoglobin >=10.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin (Hgb) >= 10.0 g/dl is acceptable)
• Adequate renal function, as defined below:
• Blood urea nitrogen (BUN) =< 30 mg/dl within 14 days prior to step 2 registration
• Creatinine =< 1.7 mg/dl within 14 days prior to step 2 registration
• Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =< 3 x normal range within 14 days prior to step 2 registration
• Systolic blood pressure =< 140 mm Hg AND diastolic pressure =< 90 mm Hg within 14 days prior to step 2 registration in the presence or absence of a stable regimen of anti-hypertensive therapy
• Prothrombin time/international normalized ratio (PT INR) < 1.4 for patients not on warfarin confirmed by testing within 1 week of step 2 registration
• Patients on full-dose anticoagulants (e.g., warfarin or low molecular weight [LMW] heparin) must meet both of the following criteria:
• No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
• In-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin

You may not qualify if…

• Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for >= 3 years; (for example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible)
• Recurrent or multifocal malignant gliomas
• Metastases detected below the tentorium or beyond the cranial vault
• Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable (except temozolomide or cediranib); prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted
• Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields
• Severe, active co-morbidity, defined as follows:
• Unstable angina and/or congestive heart failure requiring hospitalization
• Transmural myocardial infarction within the last 6 months
• Evidence of recent myocardial infarction or ischemia by the findings of S-T elevations of >= 2 mm using the analysis of an electrocardiogram (EKG) performed within 14 days of step 2 registration
• New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to step 2 registration
• History of stroke, cerebral vascular accident (CVA) or transient ischemic attack within 6 months
• Serious and inadequately controlled cardiac arrhythmia
• Significant vascular disease (e.g., aortic aneurysm, history of aortic dissection) or clinically significant peripheral vascular disease
• Evidence of bleeding diathesis or coagulopathy
• Serious or non-healing wound, ulcer, or bone fracture or history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to step 2 registration, with the exception of the craniotomy for tumor resection
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 2 registration
• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of step 2 registration
• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
• Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol
• Active connective tissue disorders, such as lupus or scleroderma, which in the opinion of the treating physician may put the patient at high risk for radiation toxicity
• Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy
• Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
• Pregnant or lactating women
• Prior allergic reaction to temozolomide
• Patients treated on any other therapeutic clinical protocols within 30 days prior to step 1 registration or during participation in the study

Where it is running

• The Kirklin Clinic at Acton Road — Birmingham, Alabama, United States
• Arizona Oncology Services Foundation — Scottsdale, Arizona, United States
• Banner University Medical Center - Tucson — Tucson, Arizona, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• Saint Joseph Hospital - Orange — Orange, California, United States
• Poudre Valley Hospital — Fort Collins, Colorado, United States
• Smilow Cancer Hospital Care Center at Saint Francis — Hartford, Connecticut, United States
• The Hospital of Central Connecticut — New Britain, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States
• AdventHealth Orlando — Orlando, Florida, United States
• Bay Medical Center — Panama City, Florida, United States
• Emory University Hospital Midtown — Atlanta, Georgia, United States
• Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States
• Queen's Medical Center — Honolulu, Hawaii, United States
• University of Hawaii Cancer Center — Honolulu, Hawaii, United States
• The Cancer Center of Hawaii-Liliha — Honolulu, Hawaii, United States
• Saint Alphonsus Cancer Care Center-Boise — Boise, Idaho, United States
• Northwestern University — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• OSF Saint Francis Medical Center — Peoria, Illinois, United States
• Carle Cancer Center — Urbana, Illinois, United States
• Radiation Oncology Associates PC — Fort Wayne, Indiana, United States
• Parkview Hospital Randallia — Fort Wayne, Indiana, United States
• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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